Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Vasculitis Calibrator Set
BIO-RAD LABORATORIES, INC.
6631800
In Commercial Distribution

  • 00847865000499 ()

  • Total Volume: 0.5 Milliliter
  • 4 Vials
6631800

  • Multiple vasculitis-associated antibody IVD, calibrator
ANA Screen Control Lot Data
BIO-RAD LABORATORIES, INC.
6631141
In Commercial Distribution

  • 00847865000079 ()

  • 1 Each
6631141

  • Multiple antinuclear antibody (ANA) screening IVD, control
ANA Screen Control Set
BIO-RAD LABORATORIES, INC.
6631131
In Commercial Distribution

  • 00847865000055 ()

  • 6 Vials
  • Total Volume: 1.5 Milliliter
6631131

  • Multiple antinuclear antibody (ANA) screening IVD, control
ANA Screen Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6631121
In Commercial Distribution

  • 00847865000031 ()

  • 1 Each
6631121

  • Multiple antinuclear antibody (ANA) screening IVD, calibrator
ANA Screen Calibrator Set
BIO-RAD LABORATORIES, INC.
6631101
In Commercial Distribution

  • 00847865000017 ()

  • Total Volume: 0.5 Milliliter
  • 7 Vials
6631101

  • Multiple antinuclear antibody (ANA) screening IVD, calibrator
Autoimmune EIA ENA Plus Screening test
BIO-RAD LABORATORIES, INC.
96EP
In Commercial Distribution

  • 00847817022388 ()

  • 96 Tests
96EP

  • Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Kallestad ANCA IFA Formalin Fixed Slides, 5 x 6 Wells
BIO-RAD LABORATORIES, INC.
29418
In Commercial Distribution

  • 00847817022357 ()

  • 5 x 6 Wells
29418

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Autoimmune EIA ANA Screening Test
BIO-RAD LABORATORIES, INC.
96AN
In Commercial Distribution

  • 00847817022319 ()

  • 96 Tests
96AN

  • Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA ANA Screening Test
BIO-RAD LABORATORIES, INC.
576AN
In Commercial Distribution

  • 00847817021688 ()

  • 576 Tests
576AN

  • Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Kallestad ANCA IFA Ethanol Fixed Slides 5 x 6 Wells
BIO-RAD LABORATORIES, INC.
29416
In Commercial Distribution

  • 00847817020162 ()

  • 5 x 6 Wells
29416

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Autoimmune EIA Anti-ß2 Glycoprotein I IgA Test Kit
BIO-RAD LABORATORIES, INC.
425-2100
In Commercial Distribution

  • 00847817018251 ()

  • 96 Tests
425-2100

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-?2 Glycoprotein I IgM Test Kit
BIO-RAD LABORATORIES, INC.
425-2080
In Commercial Distribution

  • 00847817018244 ()

  • 96 Tests
425-2080

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-ß2 Glycoprotein I IgG Test Kit
BIO-RAD LABORATORIES, INC.
425-2060
In Commercial Distribution

  • 00847817018237 ()

  • 96 Tests
425-2060

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgA Test Kit
BIO-RAD LABORATORIES, INC.
425-2040
In Commercial Distribution

  • 00847817018220 ()

  • 96 Tests
425-2040

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgM Test Kit
BIO-RAD LABORATORIES, INC.
425-2020
In Commercial Distribution

  • 00847817018213 ()

  • 96 Tests
425-2020

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgG Test Kit
BIO-RAD LABORATORIES, INC.
425-2000
In Commercial Distribution

  • 00847817018206 ()

  • 96 Tests
425-2000

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Kallestad Anti-Mitochondrial Microplate EIA
BIO-RAD LABORATORIES, INC.
31021
In Commercial Distribution

  • 00847817016257 ()

  • 96 Tests
31021

  • Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)
Kallestad ANCA IFA COMBI Slides, 5 x 6 + 6 Wells
BIO-RAD LABORATORIES, INC.
29419
In Commercial Distribution

  • 00847817016233 ()

  • 5 x 6 + 6 Wells
29419

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA IFA Ethanol Fixed Slides, 5 x 12 Wells
BIO-RAD LABORATORIES, INC.
29417
In Commercial Distribution

  • 00847817016219 ()

  • 5 x 12 Wells
29417

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA Blotting Paper, 10 x 12 Wells
BIO-RAD LABORATORIES, INC.
29415
In Commercial Distribution

  • 00847817016196 ()

  • Box of 12
29415

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA Blotting Paper, 10 x 6 Wells
BIO-RAD LABORATORIES, INC.
29414
In Commercial Distribution

  • 00847817016189 ()

  • Box of 12
29414

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA Coverslips, 12
BIO-RAD LABORATORIES, INC.
29413
In Commercial Distribution

  • 00847817016172 ()

  • Box of 12
29413

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA Phosphate Buffered Saline, 8.6 g
BIO-RAD LABORATORIES, INC.
29412
In Commercial Distribution

  • 00847817016165 ()

  • 8.6 g
29412

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA Anti-Human IgG Conjugate, 5 mL
BIO-RAD LABORATORIES, INC.
29411
In Commercial Distribution

  • 00847817016158 ()

  • Total Volume: 5 Milliliter
29411

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA Mounting Medium, 5 mL
BIO-RAD LABORATORIES, INC.
29410
In Commercial Distribution

  • 00847817016141 ()

  • Total Volume: 5 Milliliter
29410

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA Evans Blue Counterstain, 1 mL
BIO-RAD LABORATORIES, INC.
29409
In Commercial Distribution

  • 00847817016134 ()

  • Total Volume: 1 Milliliter
29409

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad ANCA Negative Control, 0.5 mL
BIO-RAD LABORATORIES, INC.
29408
In Commercial Distribution

  • 00847817016127 ()

  • Total Volume: 0.5 Milliliter
29408

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control
Kallestad Sample Diluent, 60 mL
BIO-RAD LABORATORIES, INC.
29407
In Commercial Distribution

  • 00847817016110 ()

  • Total Volume: 60 Milliliter
29407

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Kallestad Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Ethanol IFA
BIO-RAD LABORATORIES, INC.
29403
In Commercial Distribution

  • 00847817016103 ()

  • 60 Tests
29403

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Kallestad pANCA Positive Control, 0.5 mL
BIO-RAD LABORATORIES, INC.
29401
In Commercial Distribution

  • 00847817016097 ()

  • Total Volume: 0.5 Milliliter
29401

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control
Kallestad cANCA Positive Control, 0.5 mL
BIO-RAD LABORATORIES, INC.
29400
In Commercial Distribution

  • 00847817016080 ()

  • Total Volume: 0.5 Milliliter
29400

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control
Autoimmune EIA Sample Diluent, 30 mL
BIO-RAD LABORATORIES, INC.
230AD
In Commercial Distribution

  • 00847817007019 ()

  • Total Volume: 30 Milliliter
230AD

  • Multiple antinuclear antibody (ANA) screening IVD, reagent
Autoimmune EIA Substrate, 15 mL
BIO-RAD LABORATORIES, INC.
220TM
In Commercial Distribution

  • 00847817006999 ()

  • Total Volume: 15 Milliliter
220TM

  • Multiple antinuclear antibody (ANA) screening IVD, reagent
Autoimmune EIA Stop Solution, 15 mL
BIO-RAD LABORATORIES, INC.
220SM
In Commercial Distribution

  • 00847817006982 ()

  • Total Volume: 15 Milliliter
220SM

  • Multiple antinuclear antibody (ANA) screening IVD, reagent
Autoimmune EIA ENA Conjugate, 15 mL
BIO-RAD LABORATORIES, INC.
220HSP
In Commercial Distribution

  • 00847817006944 ()

  • Total Volume: 15 Milliliter
220HSP

  • Multiple extractable nuclear antigen (ENA) IVD, reagent
Autoimmune EIA Stop Solution, 15 mL
BIO-RAD LABORATORIES, INC.
220HAN
In Commercial Distribution

  • 00847817006913 ()

  • Total Volume: 15 Milliliter
220HAN

  • Multiple antinuclear antibody (ANA) screening IVD, reagent
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MDMA, MET, MTD, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5225
In Commercial Distribution

  • 00847817001352 ()
1945225

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI2000, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5183
In Commercial Distribution

  • 00847817000799 ()
1945183

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test MTD
BIO-RAD LABORATORIES, INC.
194-5191
In Commercial Distribution

  • 00847817000669 ()
1945191

  • Methadone IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, MTD, OPI, PCP, TCA, THC
BIO-RAD LABORATORIES, INC.
194-5228
In Commercial Distribution

  • 00847817000621 ()
1945228

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5209
In Commercial Distribution

  • 00847817000607 ()
1945209

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, COC, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5200
In Commercial Distribution

  • 00847817000591 ()
1945200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, OPI, PCP, TCA, THC
BIO-RAD LABORATORIES, INC.
194-5230
In Commercial Distribution

  • 00847817000393 ()
1945230

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MDMA, MET, MTD, OPI, OXY, PCP, TCA, THC
BIO-RAD LABORATORIES, INC.
194-5221
In Commercial Distribution

  • 00847817000386 ()
1945221

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BZO, COC, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5216
In Commercial Distribution

  • 00847817000379 ()
1945216

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, MTD, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5182
In Commercial Distribution

  • 00847817000348 ()
1945182

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00102C
In Commercial Distribution

  • 00847661005780 ()
00102C

  • Multiple blood-borne virus antigen/antibody IVD, control
VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00102B
In Commercial Distribution

  • 00847661005773 ()
00102B

  • Multiple blood-borne virus antigen/antibody IVD, control
Lyphochek Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
27125X
In Commercial Distribution

  • 00847661005681 ()
27125X

  • Multiple clinical chemistry protein IVD, control
Lyphochek Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
27126
In Commercial Distribution

  • 00847661005674 ()
27126

  • Multiple clinical chemistry protein IVD, control
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